Biofrontera Inc. receives FDA approval for new formulation of Ameluz

Biofrontera announced that its licensor Biofrontera Bioscience GmbH has received approval from the U.S. Food and Drug Administration, FDA, for a new formulation of Ameluz for the treatment of actinic keratosis , AK. The new formulation is covered by the License and Supply Agreement between the two companies. “We anticipate that the new formulation, which will be implemented in all U.S. Ameluz production beginning in 2024, will improve the safety profile of the topical gel by replacing propylene glycol, an ingredient common in semi-solid formulations, with ingredients already existing in Ameluz,” the company said. “Receipt of FDA approval reflects Biofrontera’s commitment to continued innovation and improving patient outcomes and experiences with photodynamic therapy to treat AK. With a reengineered formulation of Ameluz, Biofrontera is not only able to deliver a superior product with reduced risk of contaminants, but also potentially benefit from extended patent protection,” stated Hermann Luebbert, Chief Executive Officer and Chairman of Biofrontera. Biofrontera Bioscience has filed a patent application to protect the new formulation given that the nanoemulsion without propylene glycol constitutes a novel invention. If granted, patent protection for Ameluz could be extended until at least 2043.